Reducing Central Nervous System–Active Medications to Prevent Falls and Injuries Among Older Adults

Key Points Question Does a health system–embedded deprescribing intervention delivered to community-dwelling older adults and their primary care clinicians reduce use of central nervous system (CNS)–active medications and medically treated falls? Findings In this cluster randomized, parallel-group clinical trial that included 2367 older adults and their primary care clinicians, medically treated falls were not reduced among those who received the intervention compared with usual care. Meaning A deprescribing intervention focused on CNS-active medications that targeted older adults and their primary care clinicians was no more effective than usual care in improving the safety profile of medication regimens and averting serious fall events.

Abbreviations: Adj, adjusted; RR, relative risk; CI, confidence interval; SDD, standardized daily dose; Rx, prescription; med, medication; diff, difference a Adjusted rates, relative risks, and corresponding 95% confidence and p-values are calculated from a Poisson regression model for the given binary outcome with an offset for proportion of days enrolled within outcome window at 9 months (90 days for discontinuation and 180 days for sustained discontinuation).Model fit using generalized estimating equations to account for correlation due to clinic randomization using small number of cluster correction.All analyses adjusted for baseline SDD dose of the given medication analyzed, age, sex, geographic region, and baseline prior fall.Adjusted rates are calculated at the population mean level of the covariate.
b First target medication is the first medication mailed to the participant at the time of study enrollment.
c Dose Reduction is defined as the change in medication dose at 9 months (average SDD over 90 days post 9 months) minus baseline dose (average SDD over 90 days pre-baseline).
d Adjusted means, mean differences and corresponding 95% confidence intervals and p-values are calculated from a weighted regression model for the continuous outcome dose reduction with the weight being number of days enrolled in the 90 day outcome window at 9 months fit using generalized estimating equations to account for correlation due to clinic randomization using a small number of cluster correction.Adjusted rates, relative risks, and corresponding 95% confidence and p-values are calculated from a Poisson regression model for the given binary outcome with an offset for proportion of days enrolled within outcome window at 15 months (90 days for discontinuation and 180 days for sustained discontinuation).Model fit using generalized estimating equations to account for correlation due to clinic randomization using small number of cluster correction.All analyses will adjust for baseline SDD dose of the given medication analyzed, age, sex, geographic region, and baseline prior fall.Adjusted rates are calculated at the population mean level of the covariate.
b First target medication is the first medication mailed to the participant at the time of study enrollment.
c Dose Reduction is defined as the change in medication dose at 15 months (average SDD over 90 days post 15 months) minus baseline dose (average SDD over 90 days pre-baseline).
d Adjusted means, mean differences and corresponding 95% confidence intervals and p-values are calculated from a weighted regression model for the continuous outcome dose reduction with the weight being number of days enrolled in the 90 day outcome window at 15 months fit using generalized estimating equations to account for correlation due to clinic randomization using a small number of cluster correction.All analyses adjusted for baseline SDD dose of the given medication analyzed, age, sex, geographic region, and baseline prior fall.Adjusted means are calculated at the population mean level of the covariate.

After Visit Summary
.avsanxiety

Alternatives for Insomnia
• Melatonin

Alternatives for Allergic Rhinitis
eAppendix.Evidence-Based Pharmaceutical Opinions The 2019 American Geriatrics Society Beers List 1 of potentially inappropriate medications recommends avoiding use of first-generation antihistamines in adults aged 65+.High-quality evidence indicates these medications increase risk of cognitive impairment, delirium, dementia 2 and urinary retention.*Although most patients do not require a taper of antihistamines, patients using higher doses for anxiety may benefit from a taper to minimize discontinuation symptoms.For patients who suffer discontinuation symptoms despite a gradual taper, the duration of the taper can be extended depending upon the pace that the patient can tolerate.
Psychotherapy.For psychotherapy for anxiety or insomnia management, refer to a Licensed Clinical Social Worker (LICSW) in your clinic if available or to KPWA Mental Health and Wellness Services.The patient may also be referred to the myStrength self-care app, free to all KPWA members, for help with anxiety or insomnia.Use the AVS smart phrase .mystrengthinformation.

Evidence-based Pharmaceutical Opinion: First-Generation Antihistamines
Brief, validated tools are available in Epic (flowsheets) for tracking changes in symptoms over time and can facilitate medication tapering/dose reduction.In addition to monitoring symptoms of the condition for which this medication was prescribed, consider also monitoring related symptoms.Available tools include: • PEG Pain Screening Tool (PEG) • Generalized Anxiety Disorder 7-item scale (GAD-7) • Patient Health Questionnaire-9 (PHQ-9) • Insomnia Severity Index (ISI) Adapted with permission of Cara Tannenbaum and Institut universitaire de gériatrie de Montréal

Symptom Monitoring During Tapering
The 2019 American Geriatrics Society Beers List 1 of drugs to avoid in older adults considers benzodiazepines and Z-drugs as potentially inappropriate medications for adults aged 65+ due to an increased risk of cognitive impairment, falls, fractures, and motor vehicle crashes, even with intermittent use.

Taper Medication
• Route to pharmacy pool for consult {.HRMCONSULT} to obtain a tapering schedule.You as the provider will need to initiate the taper and work with the patient.
• Implement and follow the benzodiazepine tapering schedule as per KPWA guidelines (see last page for pictorial representation for patients).
• Implement the Z-drug tapering schedule as per KPWA guidelines: Decrease the number of days per week that the patient takes the medication (e.g., 6 nights per week x2 weeks, then 5 nights per week x2 weeks, etc).
Psychotherapy.For psychotherapy for anxiety or insomnia, refer to a Licensed Clinical Social Worker (LICSW) in your clinic if available or to KPWA Mental Health and Wellness Services.The patient may also be referred to the myStrength self-care app, free to all KPWA members, for help with anxiety or insomnia.Use the AVS smart phrase .mystrengthinformation.
For insomnia, recommend a Cognitive Behavioral Therapy workbook; several are listed in the After Visit Summary material .avsinsomniaptinfo.
Brief, validated tools are available in Epic (flowsheets) for tracking changes in symptoms over time and can facilitate medication tapering/dose reduction.In addition to monitoring symptoms of the condition for which this medication was prescribed, consider also monitoring related symptoms.Available tools include: • PEG Pain Screening Tool (PEG) • Generalized Anxiety Disorder 7-item scale (GAD-7) • Patient Health Questionnaire-9 (PHQ-9) • Insomnia Severity Index (ISI) Evidence-based Pharmaceutical Opinion: Sedative-Hypnotics (Benzodiazepines and Z-drugs) © 2024 Phelan EA et al.JAMA Network Open.

Alternatives for Anxiety
• Selective serotonin reuptake inhibitor

Taper Medication
• Route to pharmacy pool for consult {.HRMCONSULT} to obtain a tapering schedule.You as the provider will need to initiate the taper and work with the patient.
Add a pharmacologic alternative, as applicable depending on the type of pain: • Scheduled acetaminophen

After Visit Summary
An After Visit Summary template is available for persistent pain: .avspainchronic.

STOP-FALLS Research Study
This study has been reviewed and endorsed by KPWA Pharmacy and Primary Care.
To minimize discontinuation symptoms, progressively taper the dose of the medication for at least two to four weeks.For patients who suffer discontinuation symptoms despite a gradual taper, the duration of the taper can be extended beyond four weeks, depending on the pace that the patient can tolerate.
Brief, validated tools are available in Epic (flowsheets) for tracking changes in symptoms over time and can facilitate medication tapering/dose reduction.In addition to monitoring pain, consider monitoring anxiety, depression, and sleep.These tools include: • PEG Pain Screening Tool (PEG) • Generalized Anxiety Disorder 7-item scale (GAD-7) • Patient Health Questionnaire-9 (PHQ-9) • Insomnia Severity Index (ISI) Adapted with permission of Cara Tannenbaum and Institut universitaire de gériatrie de Montréal

After Visit Summary
.avspainchronic

Suggested Strategies
The 2019 American Geriatrics Society Beers List 1 of potentially inappropriate medications recommends avoiding use of tricyclic antidepressants in older adults.High-quality evidence indicates these medications increase risk of falls, fractures, cognitive impairment, dementia, 2 and urinary retention.To minimize discontinuation symptoms, progressively taper the dose of the medication by a fixed amount for at least two to four weeks.For patients who suffer discontinuation symptoms despite a gradual taper, the taper duration can be extended beyond four weeks, depending on the pace that the patient can tolerate.
Psychotherapy.For psychotherapy for depression and/or insomnia management, refer to a Licensed Clinical Social Worker (LICSW) in your clinic if available or to KPWA Mental Health and Wellness Services.The patient may also be referred to the myStrength self-care app, free to all KPWA members, for help with depression, insomnia, or chronic pain.Use the AVS smart phrase .mystrengthinformation.

Alternatives for Insomnia
• Melatonin

STOP-FALLS Research Study
This study has been reviewed and endorsed by KPWA Pharmacy and Primary Care.
Brief, validated tools are available in Epic (flowsheets) for tracking changes in symptoms over time and can facilitate medication tapering/dose reduction.In addition to monitoring symptoms of the condition for which this medication was prescribed, consider also monitoring related symptoms.Available tools include: • PEG Pain Screening Tool (PEG) • Generalized Anxiety Disorder 7-item scale (GAD-7) • Patient Health Questionnaire-9 (PHQ-9) • Insomnia Severity Index (ISI) Adapted with permission of Cara Tannenbaum and Institut universitaire de gériatrie de Montréal

Symptom Monitoring during Tapering
Medicines Linked to Falls* Many older adults are not aware medicines increase fall risk: • Less than one-third of older adults taking a medicine linked to falls know that the medicine increases the risk of falls.• However, approximately 60% of older adults are willing to reduce or stop their medicine if their physician recommends it.
How to start the conversation with your patient: • "You may have received a brochure at home regarding your medicines and the risk of falls.Would it be okay if we talked about that today?" • "As people age, their bodies handle medicines differently.A medicine that was safe for you in the past may not be safe anymore.I'd like to talk with you about adjusting your medications so that your regimen is as safe for you as possible.How does that sound?" • "I am worried about your use of [medication].This medication has been linked to falls.I have some ideas about how we might work together on adjusting your medications to lower your fall risk.Would you like to talk about it?" *Medication classes linked with falls in older adults include: opioids, benzodiazepines, z-drugs, skeletal muscle relaxants, tricyclic antidepressants, and first-generation antihistamines.

Resources:
• For more information about tips and evidence-based tools for deprescribing, click here for short (3 minute) videos.• For a printable PDF pocket guide to the 2019 American Geriatrics Society Beers Criteria, click here.

Sedative-Hypnotics
Safer treatments than sedative-hypnotics exist for treating anxiety and insomnia in older adults: • Benzodiazepines and z-drugs only increase sleep by a small amount (zolpidem: 11 minutes), and tolerance may develop quickly.Risks often outweigh benefits, including unawareness of activities during sleeping (e.g., driving) and next day impairment.• Benzodiazepines and z-drugs increase the risk of falls and fractures, even when used for short periods of time or as needed.• Cognitive Behavioral Therapy for Insomnia (CBTi) has been found to improve sleep onset, total amount of sleep, and sleep quality and is safer than benzodiazepines and z-drugs.• CBTi and a written tapering protocol are tools that can help patients successfully stop their sedative-hypnotics.• You can easily refer patients to effective resources using dot phrases: o .avsinsomniaptinfo(AVS, information on sleep hygiene) o .mystrengthinformation(a referral to the MyStrength app including interactive modules based on CBTi principles) How to start the conversation with your patient: • "I'm worried about you staying on your sleeping pill.Although it may be effective for a short time, it is not the best long-term treatment.Would you be willing to talk about other options?"• "Even if you take a low dose or have not had problems with this medicine in the past, your body changes over time, and you become more vulnerable to side effects as you get older.How does trying a lower dose of [medication] sound?"Resources: • For more information about tips and evidence-based tools for deprescribing, click here for short (3 minute) videos.• KPWA clinical guidelines for: o Benzodiazepine and Z-Drug Safety here.o Insomnia here.

Opioids
Many older adults manage pain without opioids and avoid opioidassociated risks: • After discontinuing opioids, some patients report positive outcomes such as less pain, improved function, and better quality of life.• Opioids can cause drowsiness, dizziness, or confusion, which can lead to car accidents, falls, and even death.• The rate of opioid-related hospitalizations is increasing fastest among adults aged 65 and older.• Opioids can lead to dependence and addiction even after taking them for a short time.
• Evidence supports the use of oral (acetaminophen) and topical treatments (NSAIDs, lidocaine, heat) and self-management strategies such as psychotherapy for the management of chronic non-cancer pain in older adults.
How to start the conversation with your patient: • "I am concerned about your continued use of opioids.Over time, opioids often stop helping with pain.However, they can continue to cause serious side effects.It may not sound possible but many people with pain actually feel better after they stop their opioid.Have you ever heard of that?• "Many people have slowly reduced their opioid dose and found safer treatments to manage their pain and improve their everyday function.Would you be willing to talk about it?"• "I am concerned about your opioid use.There are a lot of risks and it doesn't seem to be making your pain and functioning to where either of us would like it to be.Would it be okay for us to discuss this more today?"• "I know pain is a major concern for you, and you've been on opioids a long time.I would like to review how this is going and explore safer, long-term alternatives.How does that sound to you?" Resources: • For more information about tips and evidence-based tools for deprescribing, click here for short (3 minute) videos.• More than 20% of older adults report using OTC sleep aids.However, the majority do not discuss OTC sleep aids with their healthcare provider.• Older adults are often unaware of OTC sleep aid side effects.
• Some may be taking more than one product containing an OTC antihistamine, without realizing it, thus getting a high dose.• OTC antihistamines can cause confusion and increase the risk of falls, and longterm use may increase dementia risk.
How to start the conversation with your patient: • "Do you take anything for sleep that you buy from the pharmacy, grocery store, or online without a prescription?I am asking because some of these medications can be harmful to your thinking and can increase your risk of falling."• "These medications are sold by many different names, most commonly Benadryl and anything that includes 'PM' in the name, for example, Tylenol PM.Have you heard of these?" • "I'm worried about you staying on this over-the-counter sleep aid.Many people have stopped this medication and found other ways to help manage their sleep problems.Would you be willing to talk about it?"

Resources:
• KPWA clinical guideline for Insomnia here.

Managing Benzodiazepine and Z-Drug Withdrawal Symptoms
Many risky medicationsincluding benzodiazepines and z-drugscan be safely deprescribed in older adults: • Recent guidelines recommend deprescribing of benzodiazepines and z-drugs to all older adults age 65+ who take these medications.• Research has found that patients are more accepting of deprescribing if information is provided on what to expect and if there is a clear plan for tapering, including monitoring for return of underlying symptoms.• Gradual taper of short-acting agents does not eliminate withdrawal symptoms but reduces their severity.When deciding on tapering doses and rates, consider using a slower rate with those with long-term use or history of psychological distress.
• Explain that it is common for a person to experience a brief (a few days to weeks) period of mild adverse drug withdrawal effects (e.g., insomnia, anxiety, restlessness) during tapering that will resolve with time.
How to start the conversation with your patient who is ready to taper: • "If you are ready to slowly reduce the dose of your medicine, we can develop a plan together.My main priority is your safety and well-being.How does this sound?"• "You might experience some short-term withdrawal symptoms, such as insomnia, anxiety, and restlessness.Any discomfort is usually temporary though.Are you interested in discussing a plan?" • "We will do this in a stepped fashion.We can always go back to the previous step and resume tapering at a slower rate.Most patients are able to successfully reduce their dose or completely stop the medicine.How are you feeling about it today?"

Resources:
• KPWA clinical guidelines for: o Benzodiazepine and Z-Drug Safety here.o Insomnia here.

Fight Prescribing Inertia
Take a proactive approach when it comes to risky medications: • Prescribing inertia is the tendency for medicines, once prescribed, to be continued for longer than they are safe or necessary.• Older adults may have concerns that reducing or stopping a medicine may worsen their symptoms.
• Clear communication about the reason for stopping a medicine and the plan to address symptoms can reduce concerns.
• Focusing the conversation on safety concerns can reduce push-back.
How to start the conversation with your patient: • "As we age, medicines that once were safe may no longer be safe.This is because our bodies process medicines differently at older ages.I want to make sure you are on the safest and most effective medicines.Is it okay if we review some of your medications today?" • "Certain medicines can cause more side effects as we age, such as increasing the risk of falling.Let's talk about your medicines." • "Although another doctor started this medicine, I want to make sure we are taking a fresh look at your medicine list now that some time has passed.Have you had any concerns or questions about your medications?"

Pursuing Opportunities for Opioid Deprescribing
Patients often make statements (or "clues") during visits that suggest openness to non-opioid pain treatments or lower opioid doses: • Some examples of "clues" are: o "[the medication] sometimes doesn't even work" [medication ineffective] o "with the higher strength, I get the brain fuzz that I don't like" [side effects] o "others have told me this medication is dangerous" [safety] • Over half of patients on long-term opioid therapy endorse at least one side effect (most commonly constipation, sedation, and nausea) during their clinic visit.Systematically asking about side effects opens up opportunities to explore patient willingness to try alternative treatments or lower opioid doses.
How to start the conversation with your patient:

Resources:
• KPWA clinical guidelines for: o Chronic Opioid Therapy (COT) Safety for Patients on COT for Chronic Non-malignant Pain here.o Non-specific Back Pain here.

Deprescribing and the Patient-Provider Relationship
Providers may be hesitant to deprescribe for fear that it may damage their relationship with their patient.However, evidence suggests that deprescribing can occur without harming the patient-provider relationship: • A majority of older adults are willing to reduce or stop their medicine if their provider recommends it.• Evidence-based strategies to support better deprescribing discussions include: o Focusing on the benefits of taking fewer medications o Acknowledging that patients' need for and tolerance of medications may change over time; this may be particularly important for patients who are new to your practice o Making the connection between potential medication side effects and symptoms that a patient is experiencing (e.g., constipation, urinary retention, erectile dysfunction, memory problems, falls) How to start the conversation with your patient: • "You mentioned that you feel you are taking too many medications.I'm concerned as well.We can work together to review your medications and try to reduce the number you are taking over the next few visits.Shall we get started today?" • "Our bodies change over time.This means that a medication that a person tolerated in the past could become less safe or start causing side effects.I'd like to review your medications and see if we can reduce any.How does this sound?"• "You've expressed concerns about [symptom].The [medication] that you are taking could be causing that.Would you be interested in trying to reduce the dose and perhaps finding an alternative to it?"

Return of Symptoms from Underlying Condition
During deprescribing, a patient may experience return of symptoms that the medicine was being used to treat: • Patients often worry that their symptoms will recur and want to know that their provider will be accessible throughout the deprescribing process.• Gradual tapering can minimize the impact of symptom recurrence and assist in identifying the lowest effective dose of a medication.• It may help to recommend self-management strategies (e.g., sleep hygiene, physical therapy) at the same time as the taper so that the patient has tools to manage their symptoms.• Ask the patient to track their symptoms (e.g., pain, depression, sleep, anxiety) using a log so that you have data to help guide the tapering process.
How to start the conversation with your patient: • ""As we [reduce the dose of / stop] your medicine, I would like you to keep track of any symptoms and let me know as soon as possible if any do occur.We will work together to address them."• "As you reduce this medication, you may notice [symptoms].These usually go away with time.You may also notice some increase in your [main symptom that the medicine was being used to treat].We can minimize this by starting some other approaches as we initiate the taper.Be patient with this process.In the end, I think you will be in a better place."

Deprescribing Triggers
Look for "triggers" or times when deprescribing is especially relevant to your patient: • Successful deprescribing can be facilitated by identifying the right time to start the discussion, such as: o After a recent fall o If experiencing a symptom that may be a side effect of a medication, such as memory trouble, dizziness, or unsteadiness with walking.• A recent systematic review found that medications that increase fall risk are not reduced following a fall-related healthcare encounter, suggesting a missed opportunity.
How to start the conversation with your patient: •

•
KPWA clinical guidelines and practice resources: o Chronic Opioid Therapy (COT) Safety for Patients on COT for Chronic Non-malignant Pain here.o Non-specific Back Pain here.o Pain Management Consulting Teams here.o For an opioid tapering AVS that includes patient self-care strategies, use .
"I'm concerned about your use of [medication].Your recent [injurye.g., hip fracture] may have been due to [medication].To help you avoid other injuries in the future, I'd like to discuss different treatment options."• "You are troubled by [symptom/complaint].This may be a side effect of [medication] that you are taking.I recommend that we try to reduce the dose of that medication and see if your [symptom] improves.What are your thoughts about this?" STOP-FALLS Research Study Email: Monica.M.Fujii@kp.orgPhone: 1-888-324-3166

(90 days SDD=0 post 15 months)
Summary of Medication Outcomes After 12 Months From Mailing for a Given Medication All analyses adjusted for baseline SDD dose of the given medication analyzed, age, sex, geographic region, and baseline prior fall.Adjusted means are calculated at the population mean level of the covariate.©2024Phelan EA et al.JAMA Network Open.eTable 5. © 2024 Phelan EA et al.JAMA Network Open.Abbreviations: Adj, adjusted; RR, relative risk; CI, confidence interval; SDD, standardized daily dose; Rx, prescription; med, medication; diff, difference

1
American Geriatrics Society 2019 Updated AGS Beers Criteria ® for Potentially Inappropriate Medication Use in Older Adults.American Geriatrics Society Beers Criteria ® Update Expert Panel.J Am Geriatr Soc 2019;67:674-694.Gray SL, Anderson ML, Dublin S et al.Cumulative use of strong anticholinergics and incident dementia: A prospective cohort study.JAMA Intern Med 2015;175:401-407.Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4358759/ 2• Route to pharmacy pool for consult {.HRMCONSULT} to obtain a tapering schedule.You as the provider will need to initiate the taper and work with the patient.

1
American Geriatrics Society 2019 Updated AGS Beers Criteria ® for Potentially Inappropriate Medication Use in Older Adults.American Geriatrics Society Beers Criteria ® Update Expert Panel.J Am Geriatr Soc 2019;67:674-694.

Suggested Strategies Consider one or more of the following: Taper opioid
American Geriatrics Society 2019 Updated AGS Beers Criteria ® for Potentially Inappropriate Medication Use in Older Adults.American Geriatrics Society Beers Criteria ® Update Expert Panel.J Am Geriatr Soc; 00:1-21, 2019. 2 Gray SL, Anderson ML, Dublin S et al.Cumulative use of strong anticholinergics and incident dementia: A prospective cohort study.JAMA Intern Med 2015;175:401-407.Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4358759/ Generate a tapering schedule that can be given to the patient using the opioid reduction calculator available at deprescribingnetwork.ca (under Professionals, Useful Tools).An example tapering schedule produced by this calculator: E-Consult to CHRONIC PAIN CONSULTATION for opioid taper schedule recommendations.Refer to Clinical Pharmacist Management Team (COMET).COMET provides longitudinal opioid taper management including a taper plan, withdrawal symptom management, opioid risk mitigation, patient education, and optimization of non-opioid analgesics and adjuvants.If you and your patient have decided to taper and agree to be managed by COMET then you may put in a referral by entering an order for "REF Clinical Pharmacist Managed Opioid Taper Program." 1

Taper Medication Route to pharmacy pool for consult if needed {.HRMCONSULT} to
obtain a tapering schedule.You as the provider will need to initiate the taper and work with the patient.
• "Many people have slowly reduced this medicine and found other ways to help manage their sleep problems and anxiety.We can talk about what you can try instead of [medication].Are you willing to try to get off [medication] if we work together on it?" Many patients find that opioids don't work that well.I'd like to discuss if this medication is helping you feel less pain and do more.What are your thoughts about this?" • "I hear your concerns about experiencing [opioid-related side effect].[Opioidrelated side effect] may be due to the [name of opioid] you are taking.It is a common side effect of this medication.Are you interested in trying to see if your side effect would get better if you tried a lower dose of [name of opioid], maybe combined with some other treatment options?" • "I am glad you brought up safety concerns.Opioids do have a lot of risks; what have you heard?" • "